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QA Specialist Senior
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Support, Client
Projektbeschreibung
QA Specialist Senior with profound Production knowledge wanted for our Aargau based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- University degree in Biochemistry, Microbiology, Pharmacy or similar
- Expertise in (micro-)biological analytics and diagnostics including aseptic working techniques
- Proficiency in manufacturing of sterile drug products and aseptic filling
- Practical knowledge of quality control and assurance in the pharmaceutical or biotechnology sector, mainly with regard to sterile products
- Languages: fluent German and English, both written and spoken
YOUR TASKS:
- Managing, coordinating the handling and decision of microbiological deviations along with defining and tracking of CAPAs for preventing repetition of deviations
- Providing microbiological troubleshooting in context with sterile drug products or aseptic processing, guaranteeing and optimising microbiological routine environmental monitoring as well as monitoring on surprise (EMOS)
- Conducting and checking aseptic working technique during Media Fills, establishing annual Media Fill program, approving of MBR (PMX and MES) and review as well as releasing procedure for all Media Fills
- Performing trend analyses and reports of the environmental monitoring coupled with the evaluating of relevant product, process and facility related microbiological aspects and the results of environmental monitoring, water analysis as well as Media Fills
- Supporting the customer inspections and registration as well as cooperating with authority reviewers in order to increase the quality of the registration documents along with dealing with related questions about the microbiology of sterile products
- Carrying out the planning and recording of due dates for sterile drug products
START: 10/2018
DURATION: 03MM+
LOCATION: Aargau, Switzerland
REF.NR.: BH13466
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
YOUR EXPERIENCE/SKILLS:
- University degree in Biochemistry, Microbiology, Pharmacy or similar
- Expertise in (micro-)biological analytics and diagnostics including aseptic working techniques
- Proficiency in manufacturing of sterile drug products and aseptic filling
- Practical knowledge of quality control and assurance in the pharmaceutical or biotechnology sector, mainly with regard to sterile products
- Languages: fluent German and English, both written and spoken
YOUR TASKS:
- Managing, coordinating the handling and decision of microbiological deviations along with defining and tracking of CAPAs for preventing repetition of deviations
- Providing microbiological troubleshooting in context with sterile drug products or aseptic processing, guaranteeing and optimising microbiological routine environmental monitoring as well as monitoring on surprise (EMOS)
- Conducting and checking aseptic working technique during Media Fills, establishing annual Media Fill program, approving of MBR (PMX and MES) and review as well as releasing procedure for all Media Fills
- Performing trend analyses and reports of the environmental monitoring coupled with the evaluating of relevant product, process and facility related microbiological aspects and the results of environmental monitoring, water analysis as well as Media Fills
- Supporting the customer inspections and registration as well as cooperating with authority reviewers in order to increase the quality of the registration documents along with dealing with related questions about the microbiology of sterile products
- Carrying out the planning and recording of due dates for sterile drug products
START: 10/2018
DURATION: 03MM+
LOCATION: Aargau, Switzerland
REF.NR.: BH13466
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND?
In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges